Evaluating nurse understanding and participation in the informed consent process

Abstract

Background:

Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates.

Research objective:

This study examines hospital-based nurses’ experiences and understandings of the informed consent process.

Research design:

This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses.

Participants and research context:

In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience.

Ethical considerations:

Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented.

Findings:

The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse.

Discussion and conclusion:

This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of patient–provider interactions and they are often presented opportunities to learn about and engage in the informed consent process.

Keywords

Clinical ethics empirical approaches ethics education informed consent professional ethics qualitative research

Introduction

Informed consent is a cornerstone of the patient–provider relationship. Indeed, the goal of the informed consent process is to provide a mechanism for patients to participate in treatment or research-related decisions with understanding of the factors relevant to their proposed care.¹ Despite the historical, regulatory, and ethical importance of informed consent, little is understood of this process in clinical practice and in particular, the role and training needs of nurses. While almost all nurses will encounter questions related to informed consent during their professional life, much of the focus has been on the responsibilities of physicians in obtaining consent from their patients.² Patient understanding and safety is the responsibility of all healthcare providers, yet some nurses may not feel confident with their role in the informed consent process. Nurses often face difficult ethical questions related to informed consent for their clinical patients on a daily basis. Exposure to clinical ethics training for nurses, including topics of informed consent, should occur throughout one’s educational process, helping to inform role formation.³ Ethics education and training opportunities provide a critical time for nurses to form their identities as clinicians and to understand the unique ethical issues that arise in the patient–provider relationship. To best address the professional and moral obligational needs of clinical nurses in the care of patients, more work is needed to better understand the role of nurses in the informed consent process within the clinical arena. Thus, the purpose of this study was to evaluate and understand nurses’ participation in the informed consent process in clinical care.

Background

Much of the research on informed consent has rightfully focused on patient–participants’ understanding of the core consent elements as they relate to participation in research. Many researchers have focused on concerns related to consent length, understandability, voluntariness, and other aspects of the research process.⁴ Yet, research is defined differently from clinical care. The Belmont Report, a guideline for the ethical conduct of research, clearly cites the differences between clinical care and research; in fact, clinical care is generally focused on meeting the preferences, goals, and treatment benefits to individual patients, whereas research might benefit individual patient–participants but its ultimate goal is to benefit future patients.⁵ Understanding the informed consent concerns in research, however, can provide insightful gains into the potential concerns that might arise from a clinical care perspective.

Many studies on informed consent in clinical research demonstrate a need to improve patient–participant understanding of elements such as the nature and purpose of the study, the risks and benefits, the right to privacy and confidentiality, the right to refusal, and more.^4,6 Informed consent respects the rights of individuals to make autonomous decisions related to their health and well-being. The same is true of consenting patients for medical treatments, clinical tests and procedures, or interventions throughout clinical care settings. Clinical care is also unique in several important ways. First, patients may feel inundated with information on clinical procedures, tests, and other aspects of their care, especially when an unplanned hospitalization occurs.⁷ Second, time to obtain informed consent within the clinical setting might be limited due to an imminent threat of harm to the patient or an emergency situation.^7,8 Third, hospitalized patients may be prone to cognitive deficits due to an extended stay, lack of sleep, or other factors that affect their understanding.⁸

Informed consent in context

Informed consent in clinical care respects the autonomous rights of patients’ participation in their medical care decisions after careful consideration of the potential risks and benefits; this is meant to ensure that individuals receive appropriate care that aligns with their health-related goals.⁷ Few research studies, however, have focused on nurse engagement in informed consent although nurses are clinicians at the bedside and are often responsible for answering questions and witnessing the informed consent process. All members of the healthcare team, including nurses, can be affected by ethical decision making, which can impact patient care.⁹ In one study that examined medical residents, less than half of the questions asked by patients regarding their procedures were correctly answered by the residents performing the procedures.¹⁰ Another study of medical students revealed that providers often engage with patients in the informed consent process with language well above that of a non-medical personnel’s comprehension.¹¹ Even though these shortcomings remain, informed consent is still regarded as an essential element of clinical care across healthcare professions, although it is not sufficient.^12
–14 A recent integrated review of the literature identified only 23 studies investigating provider knowledge, attitudes, and behaviors related to patient capacity to consent to or refuse treatment in clinical care.¹⁵ Only four of the studies included nurses in their sample, none of which were conducted in the United States. Although this review was focused on consent capacity, many medical specialty providers identified ethical issues in clinical care related to consent, particularly patient incapacity and treatment refusals. In some international cases, the authors noted that nurses would override previous expressed wishes if they believed it was in the best interest of patients.¹⁵ This calls for more research to better understand nursing’s role in informed consent and how nurses evaluate the unique circumstances in which they find themselves in the day-to-day care of patients and families.

The patient advocacy role and responsibilities of nurses in clinical practice is well established both nationally and internationally.^2,16 In advocating for patients and families, nurses must have a skillset to ethically and appropriately engage in the informed consent process with fellow providers, as well as with their patients and families. Early work by Aveyard et al. in the United Kingdom wrote the following: “the principles of informed consent should inform nurses’ approach to all aspects of care-giving. Nurses should approach all aspects of patient care with the intention of informing patients to the level required by them to make meaningful decisions.”¹⁷ Nursing education that includes ethical inquiry throughout the curriculum is central to the patient–provider relationship, as nurses participate in all facets of patient care, including consent. Canadian researchers identified a lack of clarity about nurse roles and responsibilities during informed consent, in part due to a deficit in ethics education and specific nursing guidelines.¹⁸ Furthermore, Susilo et al.¹⁹ found that nurse participation in the informed consent process is significantly influenced by educational preparedness. Grady et al.²⁰ also found that ethics preparedness and ethics confidence were related to nurses taking moral action. However, shortcomings in ethics education remain with no uniformity in teaching or evaluating ethical comprehension.²¹ Nursing education cannot neglect informed consent without potentially compromising patient safety. Promoting patient safety and improving clinical nursing education require reflection on the skills necessary to better execute nursing’s unique role in the care of patients and families. This qualitative study explores hospital-based practicing nurses’ experiences, understanding, and knowledge of the informed consent process in clinical practice at one large academic institution in the United States.

Methods

Design

This exploratory qualitative descriptive design examined hospital-based practicing nurses’ experiences and understanding of the informed consent process in the clinical setting. At the time of enrollment, all participants completed a brief demographic survey (Table 1) and answered questions regarding their experiences with the informed consent process. All nurses participated in a semi-structured interview, which provided them the opportunity to describe their experiences within the context of the proposed research aims.¹⁷ Semi-structured interview guides, consisting of questions and probes were used to stimulate discussion with participants. For example, some of the interview questions asked nursing respondents the following: (1) “Can you share with me an experience in the clinical setting where informed consent was obtained? (2) “Can you explain what informed consent looks like on your unit?” and (3) “Can you share with me an experience when perhaps a patient asked you about informed consent?” We also asked nurses about the resources that were available to them to assist with informed consent and the types of training and skills they perceived were necessary to feel comfortable and confident with informed consent; and if any of this training was received in the undergraduate baccalaureate program. An interpretive approach presented us with an understanding of the complex issues associated with informed consent and the opportunity to evaluate nurses’ involvement in the process (The interview guide is available upon request).

Table 1.

Sample descriptive.

	N	Mean	SD
Age	20	36.6	9.6
Years of RN experience	20	12.2	9.7
Years in current RN position	20	8.0	8.0
	N	%
Education in addition to Bachelor of Science in Nursing
Diploma	1	5
Associates	2	10
Masters	3	15
Ethics training or coursework
Basic professional training	13	65
Advanced professional program	2	10
In hospital training	6	30
Continuing education program	3	15
Other	1	5
Never had any ethics training or coursework	4	20
Current practice
Med/surgical	5	25
Critical care	11	55
Oncology	3	15
Other	1	5
Gender
Female	19	95
Male	1	5
Race
White/Caucasian	17	85
Black/African American	2	10
Other	1	5
Previously worked as a research coordinator or research assistant in a study with human subjects
Yes	5	25
Have ever completed Collaborative Institutional Training Initiative (CITI) training
Yes	10	50

SD: standard deviation.

Sampling

Maximum variation sampling, a form of purposive sampling, was used to recruit baccalaureate prepared clinically practicing nurses at a large northeastern academic medical center in the United States. Participants were recruited via email and through the Department of Nursing and Research Science at the selected institution. To increase variation, nurses from clinical units of various acuity levels were sampled (i.e. medical/surgical, oncology, and intensive care). These units were purposively chosen to provide a broader breath of experiences about informed consent for clinical care decisions. This type of sampling affords an opportunity to include perspectives from different types of clinical units, diverse patient populations with varying acuity levels, and different experiences of nurses within these units.

This sampling provided diversity in nursing experience, while limiting the sample to a population with similar academic training. Participants were eligible to participate in the study if they were baccalaureate prepared, currently employed as a registered nurse in an inpatient clinical setting, and could provide informed consent. Interviews were conducted either by telephone or in person throughout the 2016–2017 academic year. Following qualitative guidelines, saturation (or when no new themes emerged) was achieved with 20 interviews.

Analysis

ATLAS.ti software was used for content qualitative descriptive analysis to identify major themes on participants’ experiences with the informed consent process.²² The analytic process included the following: first, interviews were transcribed and read in full to achieve full immersion in the data; second, two of the authors began coding the data while data collection was simultaneously occurring; third, first-level coding was used to sort codes into categories; fourth, emergent categories were organized by placing codes into meaningful clusters; and finally, discussions with all authors on the finalization of thematic categories occurred. Additionally, a data dictionary was developed to operationalize definitions for each cluster and to systematically identify thematic findings.

Several steps were taken to enhance the qualitative rigor and trustworthiness of the data. As indicated above, an analytic tool (ATLAS.ti) was used for coding interview transcripts and as a systematic search aid for the data. It is also important to ensure credibility of the data; here, we used representative quotations from the transcribed text when identifying emerging themes. In addition, peer debriefing with all authors of the study ensured consensus on codes applied to the text using the study codebook. This allowed for discussion on emergent patterns and themes and substantiation of the data collected.²³ To minimize bias, a traceable audit trail of coding decisions and memos was made available throughout the analysis for all authors to review. Reflexivity was also built into the data analysis to minimize bias through research team meetings to discuss experiences and data issues.²⁴ Finally, two of the authors analyzed the data set and compared the coding categories and themes to reduce potential bias and enhance validity.

Participants

In all, 20 full-time baccalaureate prepared registered nurses participated in the study. Sociodemographics of the sample are presented in Table 1. Participants had a mean age of 36.6 years (standard deviation (SD): ±9.6), were predominantly White (85%), and female (95%). The majority of nurses practiced in critical care units (55%) with 25% practicing in medical/surgical units, 15% in oncology units, and 5% in “other” clinical practice settings. Nurse participants had a mean of 12.2 years of nursing experience (SD: ±9.7), and reported practicing in their current clinical setting for 8 years (SD: ±8.0). Additionally, 20% of participants reported never having had any ethics coursework or training. One of four participants previously worked as research coordinators or assistants in studies with human subjects, and 50% of the total sample completed human subjects training (Collaborative Institutional Training [CITI]) (Table 1).

Ethical considerations

This study was approved by the University of Pennsylvania Institutional Review Board. Participation in this study was voluntary, involved minimal risk, and included no invasive measures. To maintain privacy of information, interviews (by telephone or in-person) were conducted in a private room away from the clinical setting. Confidentiality of the data was maintained through participant ID numbers and participant survey data was only available to the investigators. Interviews were transcribed and stored on a password-protected firewalled secure drive at the authors’ institution.

Findings

All participants reported being involved with the informed consent process in some way. Of note, 90% of the sampled nurses reported witnessing or participating in the informed consent process in the past month and 80% admitted to being asked by patients to clarify the informed consent document. Despite this level of involvement, 45% of the nurses involved in this study disagreed with the following statement, “I, as a nurse, have a defined role in the informed consent process.” The interviews consistently revealed that nurses participate in the informed consent process through addressing the needs of their patients and do so without clearly delineated guidelines regarding the nursing role as it pertains to informed consent. As noted below by a participant in the study,

I feel like it’s important and that I just feel…there’s opportunities for us to be involved [in the informed consent process]. I feel like it probably, like I said, it gets missed a little bit kind of, you know, ‘cause there’s no…there’s no standard practice or anything like that. (Medical Surgical Nurse)

While the sampled nurses referenced several ways of engaging in the informed consent process, three major thematic nursing roles emerged from the data: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse.

Communicator

The sample largely recognized that explaining a treatment or procedure to patients was the responsibility of the performing practitioner. However, nurses also recognized that they played integral roles in identifying and communicating information for patients. In fact, 80% of our participants agreed with the statement that they have been asked by patients to clarify the informed consent document in the past month as indicated by three comments presented below:

So sometimes there’s that lack of communication, but once I know what’s happening and why, then I feel like I’m the person who translates in English to the patient, like layperson’s English, like what’s actually happening…I feel like the doctors oftentimes use terminology that the patient doesn’t understand, and then they just feel so overwhelmed they don’t even ask questions until they know that they can talk to someone who will say it in a way that they do get. So then I feel like then my role is to explain it to them actually. (Medical Surgical Nurse)

We do offer our service as a patient advocate in order explain those things in maybe more layman’s terms or, you know, just kind of with more of a patient-centered touch. (Medical Surgical Nurse)

It just depends on like how much of an understanding did you [patient] have on this? Do I need to go back and get them [the consenting physician]? I think the nurse’s role should be almost the double-check. Make sure, through casual conversation, the patient actually does understand it [the procedure they are consented for]. (Critical Care Nurse)

Moreover, 90% of the sample agreed that it is within their scope of practice to evaluate patient comprehension associated with informed consent. This particular element of informed consent, however, can raise significant ethical issues for nurses, particularly when they perceive a lack of patient understanding. In fact, the majority of nurses in the sample agreed that patient safety is linked to patient comprehension of informed consent (N = 19). Nurses also reported connecting patients to information; this was manifested by connecting patients with the people, often physicians, or resources necessary to enhance their understanding. Examples are provided below:

As a nurse I’m kind of being like a conduit between two people. (Critical Care Nurse)

I think we need to get everybody on the same wavelength. (Oncology Nurse)

[I]t’s hard because there’s so many things people get consented for. You can’t really know about all those things, and it’s not really our place to explain some of those things. But…[i]f there’s something you don’t know, it’s okay saying “I’m not sure.” I can find out for you, or I can have something come back and explain it to you. (Medical Surgical Nurse)

It’s a space for nursing to be like, hey, like can we have a goals of, like a goals of care conversation with this person [patient being consented]? And that’s like a good forum…because it’s very nurse-driven. (Critical Care Nurse)

Closely linked to this theme is that of advocacy, a role that is inextricably linked with nursing.

Advocacy

Unsurprisingly, the nurse as a patient advocate was ubiquitous throughout the interviews. Nurses linked participating in informed consent as a necessity to better understanding and caring for patients. This is seen in the quotes below:

[S]o not only like keeps you informed as to what’s happening with the patient, which is important for nursing to know like what’s going on to be able to best take care of somebody. (Medical Surgical Nurse)

I think the patient appreciates that the nurses know what’s going on an if they have any questions the nurses would be able to answer them. (Medical Surgical Nurse)

Whether acting as a witness or discussing a specific component of consent, being aware of the process is a way to connect patient care. Participants discussed recognizing when further care coordination was necessary to meet the needs of the patient:

I would say to advocate for the patient, to make sure they’re understanding, to make sure they don’t feel intimidated to ask question. (Medical Surgical Nurse)

Sometimes [the patient] will forget something and I’ll say, “oh, it’s written here that you’re getting this done as well.” But sometimes they’ll say something totally different, and then, you know, that’s when typically, we get the doctors back involved because there was some miscommunication. (Medical Surgical Nurse)

We’re in a capacity for advocating, you know if there was something that came up as a concern previously without the presence of the surgeon or the anesthesiologist…that we as a nurse to that patient would then remind them “Hey, remember you had a couple of questions about XYZ” or “Did you want me to make sure that your wife is present?” (Oncology Nurse)

Advocacy largely manifested as nurses using their voices to address providers and requesting a circling back to patients when further explanation or attention to a particular issue was necessary. The nurses in this sample described feeling comfortable doing so. However, they also indicated advocacy did not always come naturally when first starting in clinical practice:

I think that you would do yourself a disservice and a disservice…a gross disservice to your patient population if you don’t eventually become comfortable enough to have that conversation as an advocate for your patient. (Medical Surgical Nurse)

If anything comes up and I’m not comfortable answering it, I’ll go tell the NP [Nurse Practitioner] or the resident and be like, hey, you need to go back and talk to them about this and this ‘cause they [the patient] still have questions. (Oncology Nurse)

Probably [after] the first year you feel like you’re not in constant moral distress or you don’t have a black cloud over your head…then I think after five years is when you can start calling yourself, no longer a novice or a beginner, but an expert…although you might never be completely comfortable with it [discussing consent with other providers]. (Oncology Nurse)

Clerical

There is no doubt that nurses in clinical practice face time constraints in managing patient needs and as a result many of the roles they maintain can become more task oriented. As one nurse describes below, informed consent is often recognized as “another task on the list”:

You know, as nurses, we have to follow up on a lot…you know, we have to…a lot of things and, you know, consent is just one of the many things that we have to follow up on. (Critical Care Nurse)

In this study, nurses often considered their role in the informed consent process to be ancillary and clerical in nature. Interviews revealed informed consent, at times, to be a checklist item, something that just needs to be signed or simply to put in the medical record. This is evident in many of the participant interviews:

[J]ust verifying that before the procedure starts that they…that somebody remembered to get consent. (Critical Care Nurse)

When someone goes for a procedure we check to make sure consent has been signed, and, um, by who. So that’s how I find out. It’s like a checklist that we have to go through. (Critical Care Nurse)

It’s almost like, you know, CYA—cover your ass—by getting the informed consent signed. (Medical Surgical Nurse)

While participant interviews were rich in experiences, some shared the monotony of the frequently occurring informed consent procedures in clinical care and the resulting lack of a more active role for nurses:

I mean I think it’s…it’s always the same. I mean it is…it is a document and they sign them. It’s always the same speech, and it’s kind of…those type of things feel pretty obvious to me most of the time. (Medical Surgical Nurse)

Limited time

Much of the discussion around consent as a clerical task was discussed in relation to nurses feeling they had limited time to fill a more central role in the informed consent process. This recurring component of time in the context of informed consent is represented in the following participant quotes from nurses practicing on different clinical settings:

I just think that there’s…really a lot of stuff to do and a lot of times there is like time constraints of like how much we’re actually able to do that adding one more thing, even though it often takes like five minutes, but just there’s just not enough time in a day to do everything. (Critical Care Nurse)

I want to say yes [that nurses have a role], but also knowing how much is put on the nurses, I don’t know that it’s fair for them to have to do an additional thing that the doctors should be able to do on their own. (Medical Surgical Nurse)

You know in an ideal world, you’d like come in the morning and look and say, okay, I have consent for blood. I have consent for surgery. I have consent for anesthesia, I have hospital consent, check, done. (Oncology Nurse)

The role of time in a nurse’s practice is not a new conversation. However, understanding if and how informed consent fits into a nurse’s responsibility is important as nurses directly and indirectly participate in informed consent while caring for their patients in any given hour of the workday.

Discussion

This exploratory study begins to more fully understand the role of informed consent in nursing clinical practice within the United States. The nurses who participated in this study provided in-depth information through sharing their experiences, knowledge, and understanding of the informed consent process within their respective clinical units. While varied roles and issues emerged and participants articulated an understanding of the function of informed consent, the process was also discussed as an ideal. Our work supports the qualitative work of Susilo et al.¹⁹ who reported that Indonesian nurses, for example, act as managers, information givers, and advocates in the informed consent process. These differing roles reflect similar themes in our American sample.

The clerical and checklist mentality sometimes associated with informed consent in practice contrasts with the ideal definitions of informed consent provided by the participants, presenting an interesting dichotomy. Participants in our study recognize the importance of informed consent and can certainly speak to its purpose and goals. In practice, however, they may experience varying levels of informed consent fatigue, that is, a desensitization or inability to address informed consent in accordance to the ideal they describe. In fact, nearly half of the participants in our study did not perceive a defined role for nurses in the informed consent process; and, with the frequency in which informed consent is required within hospital-based systems of care, it becomes viewed much more as a clerical need. Or seen as, “just another task” to be completed. More complicated for nurses, however, is how this ideal of informed consent manifests in the day-to-day clinical setting and as a component of their patient care. The ethical challenges nurses face and the roles they play in assessing, observing, and in some instances, obtaining informed consent requires further dialogue on educational training needs within institutional settings as well as academic curricula. Interestingly, 20% of nurses in this study reported no ethics training, yet the majority (60%) voiced interest in learning more. This is consistent with previous research by Grady et al. who reported that approximately 23% of nurses in their study did not have ethics education.²⁰ In their work, those with no ethics education were less likely to take moral action and reported less confidence. Additionally, the lack of a clear role definition and standard educational training may contribute to varied nurse participation in the informed consent process.^13,14,20

Historically, both undergraduate student nurses and experienced registered nurses may struggle in their ethical responsiveness to address areas of concern across healthcare settings.^25,26 In their survey of practicing nurses in four states in four different census regions of the United States more than 10 years ago, Ulrich et al.²⁷ found that informed consent remains one of the most frequently cited ethical issues occurring in everyday clinical practice. Today, this still remains true; 30% of our participants disagreed with the statement that their undergraduate education prepared them to actively engage in the informed consent process. Despite this lack of preparation in undergraduate training, three-quarters of nurses in the study reported that when unsure about a component of the informed consent process, they know what resources are available on their unit to assist them. Future research must evaluate what these resources are, identify who manages these resources, and assess their usefulness to nurses and others in mitigating concerns. Many nurses expressed interest in receiving further training opportunities on informed consent. Multiple approaches to training would be beneficial, including in-house and unit-based discussions on ways to improve communication on the informed consent process.

The thematic finding that nurses viewed informed consent as a task needing to be completed, and perhaps a sense of fatigue toward the process, deviates from its true ethical purpose. Future research should begin to understand what is needed to help nurses become more engaged in discussions surrounding the preferences and goals of their patients, including informed consent. Furthermore, identifying pre-existing clinical resources that nurses may already use, such as nurse managers and clinical specialists, offer many opportunities to integrate mentorship activities into existing nurse training pathways. Interestingly, the majority of participants in our study believed that safety is linked to patient comprehension of the informed consent process. However, more research is needed to further explore this finding. Research that focuses on the relationship between ethics education of clinical nurses and patient safety would be instructive.

Informed consent is part of every patient, provider, and family encounter across differing clinical practice environments. As such, healthcare institutions and nursing educational programs must strive to develop and provide targeted ethics-related interventions to educate and retain an informed nursing workforce prepared to meet the complex needs of patients. The present research illustrates important findings for nurse education as well as the continuing education for nurses in clinical practice. Undergraduate baccalaureate curriculums should offer ethics education focused on empowering nurses to have both an understanding of and an active role in the informed consent process, as they develop their roles as communicators and advocates for patients and families. Ethics training, specifically on informed consent, is needed and wanted by most nurses in clinical settings. As frontline providers, nurses are continuously interceding on behalf of their patients and families; as such, they are well positioned to identify any unmet information needs that might exist.²⁸ Institutional policies should also formally address the role of nurses in the clinical setting and the value they bring to the informed consent process for the patients and families under their care. Finally, more work is needed on the facilitators and barriers associated with interprofessional teams and how nurses can work with their physician counterparts to inform patients and families on their clinical care treatment interventions.

Several limitations warrant discussion. First, this study focused on baccalaureate prepared clinical nurses practicing in an urban northeastern hospital within selected units. Clinical nurses who practice in other regions may be very different in their experiences, evaluations, and understanding of informed consent. Nurses who were educationally prepared at the Associate Degree level as well as those with graduate education may also differ in important ways. Second, the small sample size, although appropriate for qualitative research, limits our ability to examine thematic differences that may exist based on varying sociodemographic characteristics and clinical practice units. Future research with larger samples and other types of clinical and practice settings would be helpful. It would also be important to examine and compare disciplinary views on informed consent with nurses, physicians, and other clinical providers. Finally, although this study was focused on clinical care, it would be helpful to examine the differences or similarities between informed consent in clinical care and informed consent in research. Do the same concerns in research such as comprehension of information, voluntariness, and weighing of the risks and benefits mirror comparable concerns in clinical care consent? Despite the limitations listed, the research provides valuable insights into clinical ethics and the needs of practicing nurses to provide ethically informed care.

Conclusion

Findings from this study suggest that despite nurses believing that they do not have a clearly defined role in the informed consent process, in daily practice nurses take on many roles. Nurses most often found themselves being communicators, translating medical jargon to patient appropriate terms, and facilitating ethical conversations between patients and providers. Furthermore, nurses found themselves occupying a critical role as patient advocates. This is understandable given nurses’ perception that there was a link between patient safety and patient comprehension regarding informed consent. Finally, nurses often considered themselves to be in a clerical role, largely checking to make sure consent documents were completed, often because of time limitations. Collectively, these thematic findings highlight clear roles nurses have in the informed consent process within one large northeastern academic medical center. This defining of the nurse’s role in the informed consent process is a fundamental first step to designing informed ethics educational interventions for nurses to ultimately continue to best meet the needs of patients and families.

Footnotes

Acknowledgements

The authors would like to thank the Office of Nursing Research for supporting this work and the Alex & Rita Hillman Foundation for their educational and training support to the authors. Additionally, the authors thank the nurse participants for sharing their experiences with the research team.

Conflict of interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by a University of Pennsylvania School of Nursing Office of Nursing Research grant.

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